Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Carvedilol Generic (ANDA 076649) by Dr. Reddy's Laboratories
FDA granted approval for ANDA 076649, a carvedilol oral tablet generic from Dr. Reddy's Laboratories, covering four strengths and prescription use.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Hikma’s Indomethacin Sodium Injection (ANDA 078713)
The FDA has approved ANDA 078713 for Hikma’s injectable Indomethacin Sodium, though the product is listed as discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants ANDA Approval for Voriconazole Injection (ANDA220043)
The FDA approved an ANDA for Voriconazole injection, a 10 mg/mL intravenous antifungal solution, sponsored by Hainan Poly Pharm.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Approval for Ethosuximide 250 mg Oral Capsules (ANDA 211928)
The FDA has approved ANDA 211928 for 250 mg oral capsules of ethosuximide, manufactured by Strides Pharma Science Limited and sponsored by ONESOURCE.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA211272 for Mycophenolate Mofetil Oral Suspension
Teva Pharm USA's ANDA211272 for Mycophenolate Mofetil oral suspension (200 mg/mL) received FDA approval, with several REMS and labeling supplements also approved.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA210929 for Tacrolimus Oral Capsules
FDA has approved application ANDA210929 for tacrolimus oral capsules submitted by Hangzhou Zhongmei Huadong Pharmaceutical, with three discontinued dosage strengths listed.
Regulatory Updates
Sep 17, 2026•1 min read
Korea issues guidance on COVID‑19 treatment supply for nursing facilities and pharmacies
Korea Disease Control Agency advises nursing homes to secure Paxlovid stocks and use Bebtelovimab based on patient condition amid rising COVID‑19 cases.
Regulatory Updates
Sep 17, 2026•1 min read
Cipla Submits ANDA077221 for Lamivudine Tablets (150 mg & 300 mg)
Cipla has an ANDA (application number ANDA077221) for lamivudine tablets in 150 mg and 300 mg strengths, with standard labeling submissions approved in 2019.
Regulatory Updates
Sep 17, 2026•1 min read
Chelsea midfielder Mihailo Mudric’s Meldonium ban lifted after four-year suspension
Chelsea FC’s Mihailo Mudric, previously banned for four years after testing positive for the prohibited metabolic modulator Meldonium, has had his sanction lifted and is set to return.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves ANDA 078126 for Fosphenytoin Sodium Injection (Now Discontinued)
The FDA approved ANDA 078126 for fosphenytoin sodium injectable in August 2007, issued multiple labeling supplements through 2022, and the product is currently discontinued.
Regulatory Updates
Sep 17, 2026•1 min read
MHRA Review Highlights RF Safety Issues in Wireless CTG Monitors
The MHRA identified signal crossover, erroneous traces and dropouts in wireless cardiotocography systems that use radio‑frequency telemetry.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Approves HIKMA ANDA062720 for Cephapirin Sodium Injection (Discontinued Products)
The FDA approved HIKMA's ANDA062720 for cephapirin sodium injectable products, all listed as discontinued, with approval dated July 2, 1987.